Comparative study of iron sucrose versus ferric Carboxymaltose in the management of iron deficiency Anaemia in pregnancy

Mahaur, Beena; Kaur, Satwant; Mahaur, Sharda

doi:10.33545/gynae.2020.v4.i3c.595

Cited by 4 publications

(7 citation statements)

References 9 publications

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“…31 Similar studies by Naqash et al, Agrawal et al, Mahaur et al and Patel et al evaluating the efficacy and safety of FCM in comparison to IS in treatment of moderate to severe anemia in Indian pregnant women, concluded FCM was more effective and safer compared to IS. [33][34][35][36] Similar findings were reported in our study. Pregnant women with moderate to severe anemia reporting in third trimester, always pose a clinical challenge as there is significant risk of impaired cardiovascular function, compromised immunity, premature delivery, low birth weight and intrauterine fetal death.…”

Section: Discussionsupporting

confidence: 92%

Comparative efficacy and safety of ferric carboxymaltose, iron sucrose and iron sorbitol in treatment of iron deficiency anemia in Indian pregnant women

Patil¹,

Tehalia²

2022

Int J Reprod Contracept Obstet Gynecol

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Background: There’s paucity of data on comparative efficacy and safety of ferric carboxymaltose (FCM), iron sucrose (IS) and iron sorbitol (ISr) in management of iron deficiency anemia (IDA) in pregnancy. Present study assessed the efficacy and safety of these iron preparations in management of IDA in Indian pregnant women.Methods: This was a single-centre, parallel-group, open-label, randomised clinical trial. Total 150 pregnant women of 24 to 34 weeks of gestation with IDA and hemoglobin between 6.5 to <9.0g/dL, were randomised to three groups to receive either FCM, IS or ISr. Primary outcome was improvement in hemoglobin and serum ferritin levels with FCM, IS and ISr. Comparative improvement in other hematological parameters, tolerability and safety were also analysed.Results: At 2 weeks, significant increase in hemoglobin of 1.86 g/dL was noted with FCM compared to 1.24 and 0.83 g/dL with IS and ISr respectively. At 6 weeks, increase in hemoglobin with FCM (4.02 g/dL) was almost two times of that with ISr (2.08 g/dL) and almost 1.4 times of that with IS (2.87g/dL). Significant improvement in serum ferritin was noted with FCM (25.59 µg/L) compared to IS (18.86 µg/L) and ISr (13.84 µg/L) at 2 weeks and also at 6 weeks (87.71 vs. 65.22 vs. 43.5 µg/L). Improvement in other hematological parameters was also significantly more with FCM compared to IS and ISr. Minor adverse effects were seen with IS and FCM. No serious adverse effects were reported in any group.Conclusions: FCM 1000 mg rapidly corrects hemoglobin and replenishes iron stores in pregnant women with moderate to severe anemia reporting in third trimester.

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Section: Discussionsupporting

confidence: 92%

Comparative efficacy and safety of ferric carboxymaltose, iron sucrose and iron sorbitol in treatment of iron deficiency anemia in Indian pregnant women

Patil¹,

Tehalia²

2022

Int J Reprod Contracept Obstet Gynecol

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“…17 In our study anemia was more common in Multigravida than in Primigravida (Group I-70%; Group II-58%). The findings were consistent with results obtained in study by, Patel Alpesh et al, Deepali Janugade, Khan S and Gupta S. A., Mahaur B et al and Beigh et al [11][12][13]17,18 Sunil et al found that 44% of patients in FCM group and 38% in Iron Sucrose group were Primigravida, while 56% of patients in FCM group and 62% in Iron Sucrose group were multigravida. 14 In the study conducted by Metgud MC et al, 56.86% of females were multigravida in FCM group and 76.9% in the Iron sucrose group.…”

Section: Discussionsupporting

confidence: 47%

Comparison of ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia in pregnancy at tertiary care centre, Western India

Papaniya,

Parmar,

Solanki

2023

Int J Reprod Contracept Obstet Gynecol

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Background: Iron deficiency anemia is the most common haematological health problem among pregnant women but can be prevented by effective measure. The study aimed to evaluate the efficacy and safety of intravenous ferric carboxymaltose (FCM) in comparison with intravenous Iron sucrose (IS) for treatment of iron deficiency anemia in pregnancy. Methods: A prospective interventional comparative study was conducted from (June 2021-June 2022) at a tertiary care hospital. Pregnant women diagnosed with moderate to severe iron deficiency anaemia were screened for the study. One hundred patients were randomized to receive either intravenous FCM or IS. Treatment effectiveness was assessed by repeat Haemoglobin (Hb) and RBC indices measurement after 4 weeks of completion of therapy. Safety was assessed by analysis of adverse drug reactions during infusion and 2 hours after infusion. Results: Mean rise in Hb at 4 weeks was significantly higher in FCM group (1.67±0.47 Vs 1.07±0.25; p<0.0001) as compared to IS group. There was also rise in other biochemical parameters like MCV and MCHC in both groups. Numbers of visits were significantly less in FCM group. No serious adverse events were noted in either group. Conclusions: Intravenous ferric carboxymaltose is more effective and safer as compared to intravenous iron sucrose in the management of anemia during pregnancy. It has advantage to administer large dose in single sitting which reduce overall cost of therapy and hence will lead to better compliance in community setting.

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“…Compared to other parenteral iron preparations, FCM has an excellent safety profile in pregnancy [ 25 ], with no [ 14 ] or minimal mild adverse effects reported by fewer patients [ 12 , 15 , 16 , 23 , 24 ]. The most common adverse effects reported, usually after ≥2 FCM doses are headache, mild local reaction, nausea, dizziness, abdominal pain, constipation, and fever and chills [ 12 , 15 , 16 , 23 , 24 ]. The present subgroup analysis also reported minimal adverse effects in 8.6% of study population which is in line with the published data.…”

Section: Discussionmentioning

confidence: 99%

“…Tere is abundant clinical evidence supporting the effective and safe use of IV FCM for correcting anemia and replenishing iron stores during pregnancy [12][13][14][15][16][17][18][19][20][21][22][23][24]. Also, compared to other parenteral iron preparations, IV FCM reported rapid correction of anemia during pregnancy [12][13][14][15][16][17][18][19][20][21][22][23][24]. Further, a large FCM dose (1000 mg) can be administered in a single setting with good efcacy and minimal adverse efects [12, 14-16, 21, 23, 24, 27].…”

Section: Discussionmentioning

confidence: 99%

“…Ferric carboxymaltose (FCM) is a third-generation parenteral iron formulation used for correcting IDA. Tere are many Indian [12][13][14][15][16][17][18][19][20] and international [21][22][23][24] clinical studies supporting the efcacy and safety of FCM in treating IDA in pregnancy. However, there is limited real-world evidence (RWE) [25][26][27][28][29] reporting the efcacy and safety of FCM in pregnancy and particularly in India.…”

Section: Introductionmentioning

confidence: 99%

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Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnancy: A Subgroup Analysis of a Multicenter Real-World Study Involving 1191 Pregnant Women

Trivedi

Chitra²,

Natarajan

et al. 2022

Obstetrics and Gynecology International

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Background. Real-world evidence of the efficacy and safety of ferric carboxymaltose (FCM) infusion in Indian pregnant women with iron deficiency anemia (IDA) is lacking. Objective. To assess the efficacy and safety of intravenous (IV) FCM in Indian pregnant women with IDA in 4 weeks in a real-life scenario. Methods. This is a subgroup analysis of our previously conducted retrospective, multicenter, observational, real-world PROMISE study. Data on demographic and hematological parameters, patient-reported adverse events, and physicians’ clinical impressions of efficacy and safety were analysed at 4 ± 1 week. Results. This subgroup analysis included 1191 pregnant women in whom IV FCM resulted in a significant increase in hemoglobin (Hb) by 2.8 g/dL and serum ferritin by 30.03 μg/L at 4 weeks ( P < 0.001 for both). In 103 pregnant women with severe IDA, there was a significant increase in Hb by 3.6 g/dL ( P < 0.001 ), and serum ferritin by 16.96 μg/L ( P = 0.12 ). In 978 pregnant women with moderate IDA, significant improvement in Hb by 2.74 g/dL and serum ferritin by 33 μg/L ( P < 0.001 for both) was noted. Similarly, there was a significant increase in red blood cell count, hematocrit, mean corpuscular volume, and mean corpuscular hemoglobin ( P < 0.001 for all). In pregnant women with mild IDA (n = 26), Hb increased significantly by 1.99 g/dL ( P < 0.001 ). Adverse effects were reported in 8.6% of pregnant women. No new safety signals or serious adverse effects were observed. Based on physicians’ global assessment, good to very good efficacy and safety of IV FCM was noted in 99.2% and 98.6% of pregnant women, respectively. Conclusions. IV FCM rapidly corrected anemia in a short period of 4 weeks with favorable safety in the second and third trimester of pregnancy with all severities of IDA (severe, moderate, and mild). The physicians’ favorable global assessment of FCM’s efficacy and safety in pregnant women with IDA supports its use in daily clinical practice. This trial is registered with CTRI/2021/12/039065.

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Comparative study of iron sucrose versus ferric Carboxymaltose in the management of iron deficiency Anaemia in pregnancy

Abstract: Iron deficiency anemia is the most common hematological but manageable health problem encountered among the pregnant women globally but more common in developing countries like India.

Cited by 4 publications

References 9 publications

Comparative efficacy and safety of ferric carboxymaltose, iron sucrose and iron sorbitol in treatment of iron deficiency anemia in Indian pregnant women

Comparative efficacy and safety of ferric carboxymaltose, iron sucrose and iron sorbitol in treatment of iron deficiency anemia in Indian pregnant women

Comparison of ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia in pregnancy at tertiary care centre, Western India

Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnancy: A Subgroup Analysis of a Multicenter Real-World Study Involving 1191 Pregnant Women

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